MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A DE C.V. BD 3-PORT BACK CHECK MANIFOLD; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MM4000
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd 3-port back check manifold was cracked.The following information was provided by the initial reporter: the iv tube was cracked.I did confirm, we are not using any alcohol or prep product when initiating the manifold.The cracking has been happening when removing the iv tubing from the manifold and when two manifolds are together, and the rn is attempting to separate.The port is cracking when this is occurring.Typically, the device is typically in use between 12-20 hours.Additional information received from the customer: any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details: no injury to patient.Can you please provide the lot number associated with reported issue? no lot# on product, we don't have the package it came in.Was there any leakage? if so, what was the fluid at the time of use? there was leakage at the port where the iv tubing broke off.Our nurse did change this out in real time and there was no real patient harm thankfully.
Additional Manufacturer Narrative
E.1.Address was not located, and (b)(6) was used.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
One photo was received for quality evaluation.The photo shows one female port of product mm4000 having the tip of an unidentified male luer, stuck in it.The image does not show damage to the reported product of mm4000, but shows that an unidentified product being stuck inside one of the ports of the reported product.The customer complaint of component damage - leak to product mm4000 could not be verified.A root cause analysis could not be conducted because the physical sample of the issue was not submitted and the damages indicated in the complaint photo do not show damage to the mm4000 but an unidentified tip of a luer connector.A device history record review could not be performed because the lot number is unknown.

• Brand Name: BD 3-PORT BACK CHECK MANIFOLD
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A DE C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A DE C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23546771
• Report Number: 9616066-2025-03467
• Device Sequence Number: 15773836
• Product Code: FPA
• UDI-Device Identifier: 10885403236488
• UDI-Public: (01)10885403236488
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: MM4000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown